FDA.reportPublic FDA data

A-TAP

Primary DI
07290102590216
Brand
A-TAP
Company
Elecam Medical Agricultural Cooperative Society Ltd.
Model
NA
Catalog number
570313
Device description
A-TAP BLS RAD
Published
2024-01-29
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
FMFSyringe, Piston

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FMFSyringe, PistonGeneral Hospital2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K231900000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K231900000A-TAP (previously called Arthrotap)Elcam Medical Acal2023-07-25FMF

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
17290102590213PackageGS160In Commercial Distribution
27290102590210PackageGS1420In Commercial Distribution
07290102590216PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
1729010259021317290102590213
2729010259021027290102590210
07290102590216072901025902167290102590216

GMDN Terms#

Term, Definition table
TermDefinition
General-purpose syringe, single-useA sterile device consisting of a calibrated barrel (cylinder) with plunger intended to be used for injection/withdrawal of fluids/gas (e.g., medication) to/from a medical device or the body (i.e., capable of both); a needle is not included. It is intended for various medical applications and is not dedicated to medication administration. At the distal end of the barrel is a male connector (typically Luer-lock/slip type) for the attachment to a hypodermic needle or an administration set. It is typically made of plastic and silicone materials and may have anti-stick plunger allowing smooth plunger movement, either manually or by a syringe pump. This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Pressure200KiloPascal

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature4 Degrees Celsius40 Degrees Celsius

Contacts#

Phone, Email table
PhoneEmail
+97246988120sales@elcam.co.il

Regulatory Flags#

DUNS number
532599255
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
17290102590213A-TAPNA5703132024-01-29
07290102590018MRVLSNA5728082016-09-24
07290102590025STP 4WAY RADNA5724882016-09-24
07290102590032STP 1 WAY RADNA5721102016-09-24
07290102590049STP LB GXL BLS RAD Large Bore Stopcock4560612020-06-01
07290102590056CSTP LB1V GXL BLS RADLarge Bore Closed stopcock4560662020-06-01
07290102590063CSTP LB 2V GXL BLSLarge Bore Closed Stopcock4560632020-06-01
07290102590070MRVLS LB1V GXL BLS RADLarge Bore MRVLS Stopcock4560642020-06-01
07290102590087MRVLS LB 2V GXL BLSLarge Bore MRVLS Stopcock4560652020-06-01
17290102590015MRVLSNA5728082016-09-24
27290102590029STP 4WAY RADNA5724882016-09-24
27290102590036STP 1 WAY RADNA5721102016-09-24

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Primary DI, Brand, Company table
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M99208012905P120LCH3Livaclean HealthCarelife (usa) Inc.FMF2026-09-30
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10192253070804MonojectCardinal Health 200, LLCFMF2026-09-21
M992MTINS01291271MedThermalCarelife (usa) Inc.FMF2026-09-18
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